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To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.

The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.

The provided text describes a 510(k) premarket notification for the Victus IV Administration Sets. However, it does not contain the detailed acceptance criteria, study design, or performance data that you've requested regarding device performance. The document explicitly states:

"The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards."

This indicates that testing was performed, but the results of that testing (i.e., acceptance criteria and reported performance) are not included in this document. Instead, this document is a summary for a 510(k) submission, confirming that the device is substantially equivalent to predicate devices. Substantial equivalence means it has the same intended use and similar technological characteristics, and any differences don't raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about "the study that proves the device meets the acceptance criteria" using the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

Here's what I can extract based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document states "performance and safety testing" was done, but gives no details about the sample size, type of test set, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI). For an IV administration set, "ground truth" would typically be established through engineering specifications, material science testing, and biological assays, not expert consensus on interpretations. No details on specific experts or their qualifications are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication methods are typically used when multiple human experts provide opinions that need to be reconciled, such as in clinical studies evaluating diagnostic accuracy. This is not mentioned or relevant for the type of device and testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI device. It is a traditional medical device (IV administration set).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Inferred: For this type of device, ground truth would be established by engineering specifications, material properties, biocompatibility standards, and functional performance benchmarks (e.g., flow rates, leak integrity, particulate matter, pyrogenicity). The document mentions "FDA recognised standards" were used, implying these types of criteria formed the "ground truth." Specific details are not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI device.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices, rather than a detailed scientific study report outlining specific performance criteria and test results. It confirms that "performance and safety testing" was conducted using "FDA recognized standards," but the specifics of those tests and their outcomes are not included in this document.

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The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.

The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:

The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.

The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.

The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.

In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.

The provided text describes a 510(k) submission for a medical device, the "NP Medical Capless Luer Activated Valve." However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria and the results of a study that quantifies device performance against those criteria. The submission states that performance requirements were met but does not provide the specific metrics or values.

Here's a breakdown of the available information based on your requested points:

1. A table of acceptance criteria and the reported device performance

The document mentions that mechanical, biocompatibility, and microbial challenge testing were performed and that the device "meets their performance requirements" or "passed all" tests. However, it does not specify the exact acceptance criteria or the quantitative results achieved. Without specific numerical values for acceptance criteria and device performance from the document, a table cannot be constructed with the requested level of detail.

Illustrative Table (Based on available qualitative information):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the tests (Mechanical, Biocompatibility, Microbial Challenge). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). Given that NP Medical, Inc. is located in Clinton, MA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA by or for the manufacturer. The testing described (mechanical, biocompatibility, microbial challenge) is typically prospective and laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and therefore not available in the provided document. The device is a physical medical device (a luer activated valve), not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through laboratory testing (mechanical, chemical, microbial) rather than interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not available in the provided document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human expert assessment where there might be disagreement in interpretations (e.g., in radiology studies). This submission describes laboratory-based engineering and biological tests for a physical device, not an interpretive process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not available in the provided document. An MRMC study is relevant for evaluating diagnostic tools, often AI-powered, where human readers interpret patient cases. The Capless Luer Activated Valve is a physical device for fluid delivery, not a diagnostic tool, and involves no "human readers" in its intended function or performance testing described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and therefore not available in the provided document. "Standalone performance" in this context usually refers to the performance of an AI algorithm alone. The NP Medical Capless Luer Activated Valve is a physical medical device, not an algorithm. Its performance is inherent in its physical and material properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be defined by engineering specifications and established test methods (e.g., pressure resistance, flow rates, number of activation cycles without failure). For biocompatibility, the "ground truth" is determined by standardized biological assays according to ISO 10993. For microbial challenge testing, the "ground truth" is the absence of microbial growth in the fluid pathway after being subjected to a known microbial load, following established microbiological testing protocols.

8. The sample size for the training set

This information is not applicable and therefore not available in the provided document. "Training set" refers to data used to train machine learning models. As this is a physical medical device, there is no "training set" in the context of AI. The device's design and manufacturing rely on engineering principles and material science, not machine learning.

9. How the ground truth for the training set was established

This information is not applicable and therefore not available in the provided document. As there is no AI training set for this physical device, there is no ground truth to be established for it.

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